Kornimate/medical-research-clean huggingface dataset:
connect: smoking cessation and lung cancer screening

Conditions: Smoking Cessation

Summary: this clinical trial studies the impact of connect on biochemically confirmed smoking abstinence among diverse current smokers who are undergoing lung cancer screening.

the study team will develop and test a novel smoking cessation intervention, connect, which will start at the time an individual is receiving lung cancer screening (lcs). connect will include an interactive video doctor which will provide participants with information tailored to their individual responses as well as proactive outreach using brief telephone calls and text messaging to follow up smokers with motivation enhancement to refer and engage patients in evidence based smoking cessation interventions (such as quitline utilization). after development and usability testing, we will conduct a small feasibility study followed by a pilot randomized controlled trial to estimate the impact of connect on biochemically confirmed 30-day smoking abstinence among diverse current smokers seen at the san francisco veterans affairs medical center and the university of california san francisco division of general internal medicine. participants will be randomized to connect or a control condition. data will include self-report from participants obtained at baseline, 1 and 3 months, and the electronic health record. outcomes will be biochemically confirmed 30-day smoking abstinence at 3 months post lcs and satisfaction as well as self-reported quit attempts, and use of evidence-based smoking cessation resources (quitline, pharmacotherapy or counseling). the knowledge gained will provide the pilot data necessary to apply for a larger study to test our novel intervention for promoting smoking cessation among a diverse population of high-risk smokers undergoing lung cancer screening.

Eligibility criteria:
inclusion criteria: * age 55-80 * male or female * english speaking * have an already scheduled low-dose computed tomography (ldct) visit * smoke at least 1 cigarette in the last 7 days * have a phone that can receive text messages. exclusion criteria: * younger than 55 or older than 80 * does not speak english * does not have a scheduled low-dose computed tomography (ldct) visit * does not smoke at least 1 cigarette in the last 7 days * does not have a phone that can receive text messages.

Keywords: quitting smoking smoking cessation tool smoking cessation quit smoking smoking cessation resources smoking cessation barriers smoking cessation intervention tool
evaluation of a disposable sound sensor for recording respiration during sleep

Conditions: Sleep Apnea (Disorder)

Summary: split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor.


Eligibility criteria:
inclusion criteria: * patients with suspected obstructive sleep apnea exclusion criteria: * lung infection * insomnia
adjunctive efficacy study of the softscan® optical breast imaging system

Conditions: Breast Cancer

Summary: the primary study endpoint -softscan adjunctive accuracy- will be used to test the hypothesis that the adjunctive combination of the softscan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone.

prospective, serially-recruited, blinded and unblinded, validation study to test that the adjunctive combination of the softscan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone. healthy volunteers and patients scheduled for tissue biopsy/excision of a suspicious breast lesion will be enrolled. reader studies will be performed in which interpreting investigators will perform blinded mammography interpretations, and reinterpretations of mammography and softscan interpretations. diagnostic accuracy will be calculated using tissue histopathology as the reference standard.

Eligibility criteria:
inclusion criteria: women between the ages of 20 and 80 years of age, who are either healthy or who are scheduled to undergo a tissue biopsy of surgical excision of a suspicious breast lesion for histopathologic diagnosis. exclusion criteria: for the healthy volunteers population, * subjects with a history of minor breast procedures involving either breast; * subjects with a history of major breast procedures involving either breast; * subjects with a history of significant acute breast abnormalities involving either breast; and * subjects with a history of significant chronic breast abnormalities involving either breast; and for referred for biopsy population, * subjects with a history of minor breast procedures involving either breast that were performed within 6 months prior to enrollment or which have not completed active healing at the time of enrollment; * subjects with a history of major breast procedures involving either breast; * subjects with a history of significant acute breast abnormalities involving either breast which have not completed active healing or resolution within 6 months prior to enrollment; and * subjects with a history of significant chronic breast abnormalities involving either breast.

Keywords: spectroscopy, near-infrared mammography breast cancer
dental pain (following third molar tooth extraction) study

Conditions: Dental Pain; Surgery, Dental

Summary: the purpose of this study is to evaluate the effectiveness of gw406381 (a cox-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction.

a pivotal phase iii, single center, randomized, double-blind, placebo-controlled, parallel group dose-ranging study to investigate the efficacy and safety of single oral doses of 10mg, 25mg, 50mg, and 70mg gw406381 and 550mg naproxen sodium in subjects with pain following third molar tooth extraction

Eligibility criteria:
inclusion criteria: * scheduled for outpatient surgical removal of at least two third molar teeth. exclusion criteria: * subjects who do not achieve moderate to severe pain. * subjects who do not use acceptable contraception. * additional medical criteria will be assessed by the investigator.

Keywords: dental pain dental surgery cox-2 inhibitor
a study of longer interval of ivt ibi302 in subjects with namd

Conditions: Neovascular Age-related Macular Degeneration

Summary: the study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of ibi302 in subjects with neovascular age-related macular degeneration.


Eligibility criteria:
inclusion criteria: 1. willing and able to sign informed consent from and comply with visit and study procedures per protocol. 2. male or female patients≥50 yrs. of age. 3. active subfoveal or parafoveal cnv secondary to neovascular amd on ffa or oct. 4. the cnv area≥50% lesion area on ffa in the study eye at screening visit. 5. bcva score of 24-78 letters using etdrs charts in the study eye at the baseline. exclusion criteria: 1. concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results. 2. subretinal hemorrhage\>50% total lesion area and/or involvement in the macular foveal, fibrosis or atrophy area\>50% total lesion area and/or involved of macular fovea; 3. presence of uncontrolled glaucoma in the study eye(defined as iop≥25mmhg, or judged by the investigators at the screening or baseline visit) 4. presence of active intraocular or periocular inflammation or infection; 5. prior any treatment of following in the study eye: * anti-vegf(vascular endothelial growth factor) therapy or anti-complement therapy within 3 months prior to screening; * laser photocoagulation within 3 months prior to screening; * photodynamic therapy or vitreoretinal surgery; * intraocular glucocorticoid injection within 6 months prior to enrollment; 6. presence of any systemic disease: including but not limited tractive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor; 7. history of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine; 8. pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period; 9. participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study; 10. other conditions unsuitable for enrollment judged by investigators
three m study (malabsorption, microbiota, mini-gastric bypass)

Conditions: Obesity (Disorder)

Summary: bariatric surgery represents the best therapeutic option to induce sustainable weight loss and to solve serious comorbidities improving the life-expectancy and the quality of life. actually the choice of the procedure is based on the surgeon's and patients preference . mini gastric bypass(mgb) is an emerging procedure offering excellent results in terms of weight loss and comorbidities (mainly metabolic) control. on the other hand, recent data indicated that the gut microbiota may mediate some of the beneficial effects of bariatric surgery and changes in the composition and diversity of the gut microbiota have been observed after ry gastric bypass (rygb) in humans as well as in mice. however, there are no prospective investigations on gut microbiota changes after mgb, despite the procedure is described as "malabsorptive" and there are no studies comparing gut microbiota shift and malabsorption entity in humans after rygb vs mgb. thereafter prospective data on the incidence of bile reflux esophageal lesions after mgb are lacking. the aim of the present multicentric prospective comparative study is to evaluate malabsorption and gut microbiota shift after laparoscopic rygb vs mgb at 1 year.


Eligibility criteria:
inclusion criteria: * bmi 40-55 kg/m2 * non smokers * primary mini gastric bypass or roux en y gastric bypass without any concomitant surgeries except hiatal hernia repair * enrollment in the two study groups will be on the basis of patient choice. exclusion criteria: * smokers * different bowel measurement (plus or minus 10%). * conversion to open surgery, reoperation * helicobacter pylori positive previous or current * free ppi 4 weeks before 6th month (after surgery) * corticosteroids, vitamine e, fish oil treatment 2 months before surgery * anti or pre- biotics treatment 2 months before surgery * chronic gastrointestinal diseases or syndromes * previous bariatric surgery (intragastric balloon excluded) * previous resective bowel surgery * previous pancreatic surgery * previous hepato biliopancreatic surgery * gallbladder gallstones

Keywords: malabsorption, mini gastric bypass, roux en y gastric bypass
open-label, multli-center, phase 1b/2a clinical trial designed to evaluate the safety and efficacy of iontophoretic dexamethasone phosphate ophthalmic solution in patients with macular edema

Conditions: Macular Edema

Summary: to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, egp-437, using the eyegate® ii drug delivery system (egds) in patients with macular edema (me)

this will be a phase 1b/2a, exploratory, open-label study, in which up to 20 eligible me patients will be enrolled at up to 5 clinical sites in the u.s. twenty eyes of 20 patients will be enrolled which means that only one eye will be treated with study treatment in patients who present at visit 1 with bilateral me. in situations where both eyes of a patient are eligible for the study, the eye with the shorter duration of me will be the study eye.9 the investigator will designate the study eye when both eligible eyes have been diagnosed with me at the same time. potential patients who are interested in participating in the study will be provided an informed consent form (icf) prior to screening. patient eligibility will be assessed at visit 1 (day 0), the baseline visit, by spectral sd-oct and measurement of iop, in addition to review of the patient's medical and ophthalmic history and recent concomitant medications history. study treatment will be administered on day 0, day 4, and day 9 (visits 1, 2, and 3). subjects will be scheduled to return to the clinic for post-treatment assessments during visits 4 and 5 (day 14 and day 21 or day 28).

Eligibility criteria:
inclusion criteria: * 1. age 18 to 90 years 2. have diagnosis of me secondary to one of the following diagnosed conditions: 1. central or branch retinal vein occlusion (crvo or brvo) with a mean cst ≥ 300µm on sd-oct images taken at the baseline visit (day 0) 2. diabetic macular edema (dme) with a mean cst ≥ 300µm on sd-oct images taken at the baseline visit (day 0) 3. cystoid macular edema (cme) secondary to having undergone a previous ppv and having a mean cst ≥ 300µm on sd-oct images taken at the baseline visit (day 0) having a history of previous positive response to steroid treatment 3. receive, understand, and sign a copy of the icf 4. be able to return for all study visits and willing to comply with all study related instructions exclusion criteria:

Keywords: iontophoresis macular edema ophthalmology
efficacy and safety of spa treatment in chronic shoulder pain due to rotator cuff tendinopathy

Conditions: Self Efficacy

Summary: to determine whether spa therapy has a beneficial effect on pain and disability in the management of shoulder pain due to chronic rotator cuff lesions, this multicentre randomized prospective clinical trial includes patients with shoulder pain due to chronic degenerative rotator cuff tendinopathy who attend french spa resorts as outpatients. subjects are randomized into two groups: immediate spa therapy (18 days of standardized treatment) and control (spa therapy delayed for 6 months). all patients continue usual treatments during the 6-month follow-up period. the main endpoint is the mean change in the dash score at 6 months. secondary endpoints are the mean change in sf-36 components, treatments used, and tolerance. the effect size of spa therapy is calculated and the proportion of patients reaching minimal clinically important improvement (mcii) is compared between groups.


Eligibility criteria:
inclusion criteria: * chronic shoulder pain (symptom duration of more than 6 months) due to primary or secondary tendinopathy of the rotator cuff. in cases of rotator cuff tendinopathy related to traumatic events, the trauma was required to have happened at least 6 months previously. corticosteroid treatment for concomitant disease could be continued at a stable dose. shoulder x-rays within the previous 18 months were required in all cases. exclusion criteria: * shoulder pain related to neurological or vascular disorders or neoplasms; referred pain from internal organs; systemic rheumatic conditions; inability to complete questionnaires because of cognitive impairment, or language difficulty; contraindication (immune deficiency, evolving cardiovascular conditions, cancer, infection, non-equilibrated diabetes mellitus) or intolerance to any aspect of spa treatment; spa treatment within the previous 6 months; steroid injection within the previous 3 months; physiotherapy in the previous month; changes in non-steroidal anti-inflammatory drug (nsaid) administration within the previous 5 days or in other analgesic drug use within the previous 12 hours.

Keywords: chronic shoulder pain rotator cuff tendinopathy sap therapy balneotherapy
effects of ad on vi in patients with cf

Conditions: Cystic Fibrosis

Summary: this study will investigate the effects of a chest physiotherapy manual technique (autogenic drainage) on ventilation inhomogeneity in patients with cystic fibrosis. lung clearance index (lci) is the primary outcome

this is a cross-over intervention assessing the effect of autogenic drainage on ventilation inhomogeneity in patients with cystic fibrosis. electrical impedance tomography and multiple breath nitrogen washout will be performed before, immediatly after and 2h post intervention. each participant will receive either aerosoltherapy alone or in combination with chest physiotherapy on 2 consecutive days.

Eligibility criteria:
inclusion criteria: * cystic fibrosis diagnosis * fev1 \> 40% * able to sustain 30min of chest physiotherapy exclusion criteria: * presence of burkoldheria cepacia or non tuberculous mycobacteria * orthopedic, neuromuscular or cardiac disorder likely to impact respiratory system * need for supplemental oxygen * cardiac pacemaker or internal cardiac defibrillator

Keywords: multiple breath washout electrical impedance tomography lung clearance index chest physiotherapy autogenic drainage cystic fibrosis
sdx-105 in combination with rituxan for patients with relapsed indolent or mantle cell non-hodgkin's lymphoma (nhl)

Conditions: Non-Hodgkin's Lymphoma

Summary: summary: this is an open label study combining rituxan and sdx-105. rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of sdx-105 on day 2 and day 3. treatment will repeat every 21 days (a cycle). treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. patients will be followed for up to 2 years or until disease progression. rationale: rituxan has been shown to increase the sensitivity of cells to chemotherapy. the combination of sdx-105 and rituxan has been effective in both the laboratory and in a recent clinical study with non-hodgkin's lymphoma patients. purpose: this study will evaluate the safety and effectiveness of sdx-105 plus rituxan in patients with non-hodgkin's lymphoma who have relapsed after taking rituxan.


Eligibility criteria:
inclusion criteria: documented b-cell nhl or mantle cell lymphoma * cd-20+ tumor * indolent nhl: follicular b-cell lymphoma, diffuse small lymphoma, marginal zone lymphoma * maximum of three prior chemotherapy regimens * age of at least 18 years at screening visit (site specific requirement may differ) exclusion criteria: * refractory to rituximab, defined as progression of disease while being treated with rituximab or progression within 6 months of the last dose of rituximab (when given either as a single agent or in combination) * previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously * use of investigational agents within 28 days of study * history of prior high dose chemotherapy with allogeneic stem cell support * history of prior radioimmunotherapy

Keywords: non-hodgkin's lymphoma nhl rituxan mantle cell mabs
a comprehensive fall prevention system for memory care: final feasibility and randomized controlled study

Conditions: Dementia

Summary: this study tests novel technology using computer vision and remote clinical review to reduce falls for residents with dementia in assisted living communities.


Eligibility criteria:
inclusion criteria: * living in a participating assisted living facility and suffering from dementia exclusion criteria: -
evaluation of bacteremia epidemiology during the covid period in one french university hospital

Conditions: Bacteremia; Catheter-Related Infections

Summary: the main objective of this retrospective cohort is to evaluate the impact of the first epidemic wave during lockdown on bacteremia epidemiology in one french university hospital.


Eligibility criteria:
o inclusion criteria : patients with positive blood culture recorded at the microbiology laboratory of university hospital of nice aged 18 years o exclusion criteria : patients with negative blood culture recorded at the microbiology laboratory of university hospital of nice
impact of practitioner and instructional set on subject perceptions and expectations of cervical spine manipulation

Conditions: Neck Pain

Summary: determine effects of perceptions and expectations on experience of cervical spine manipulation

the purpose of this study is to better understand how therapists may affect a patient's thoughts/ beliefs/ opinions on cervical spine (neck) manipulation. current evidence suggests that patients who have a positive expectation about neck manipulation are more likely to report benefit from it, and we wish to determine if the perceived experience level of the therapist and the words they use to describe neck manipulation will affect the patient's perception.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years; 2. must report having no current episode of mechanical neck pain; 3. must be willing to participate; 4. must indicate they have not had their neck manipulated by a physical therapist, osteopath or chiropractor within the last 5 years. exclusion criteria: 1. 'red flag' items indicated in your neck medical screening questionnaire such as: history of a tumor, bone fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, heart disease, and stroke. 2. history of neck whiplash injury. 3. diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) in both arms. 4. presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands or face, muscle wasting in the hands, altered taste, and presence of abnormal reflexes. 5. evidence of neurological signs suggesting nerve root entrapment (pinched nerve in the neck). 6. prior surgery to your neck or upper back. 7. a medical condition which may change your sensation of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency). 8. diagnosis from your physician of fibromyalgia syndrome. 9. currently pregnant, or think you may be pregnant.